FDA applicant

Vertiflex, Inc.

San Clamente, CA5 decisions2008–20120 recalls

FDA records 5 decisions for Vertiflex, Inc. (San Clamente, CA) from 2008 to 2012: 5 510(k) clearances. Most are in product codes KWP (Appliance, Fixation, Spinal Interlaminal) and NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 20 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Vertiflex, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2008high 3 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Vertiflex, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vertiflex, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Vertiflex”

FDA records each applicant name separately; these may or may not be the same firm.

Vertiflex (Tm), Incorporated 2

Vertiflex, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Vertiflex”